# K964352: Torque Device

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jan 28, 1997 after 88 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903606 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903606: Guidewire Torque Device and Guidewire Introducer, North American Instrument Corp. (1990) Summary page 1.
- K936032: Torque Device, Merit Medical Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K011646: Neuroedge Infusion  Catheter (2001), 0 descendants of its own

## Indications for use
The device is used to facilitate the manipulation of a guidewire into a vein or artery.

Source page: https://510kreport.com/device/K964352
Methodology: https://510kreport.com/methodology